TRT as an Adjunctive ERAS Therapy in ESRD Patients Undergoing Kidney Transplantation
NCT ID: NCT07287800
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
50 participants
INTERVENTIONAL
2025-07-01
2027-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Participants will be highly-listed hypogonadal men, defined as total testosterone level \<300 on two occasions with clinical symptoms of hypogonadism, with ESRD who are expected to receive a kidney transplant within 6 months. Participants will be started on TRT, ideally for at least 3 months prior transplantation. The investigators will perform a subset analysis to evaluate if there is a significant difference in our endpoints by comparing these two subgroups (Three months or more receiving TRT vs. Less than three months receiving TRT). There will be no cut-off time for pre-transplant TRT. Following the intervention period, a historical control cohort of age-matched and health-matched patients will be identified, who have followed a standard transplant protocol that does not incorporate TRT. The primary outcome will evaluate safety, including 30- and 90-day adverse events, 3, 6, and 12-month allograft survival, and overall patient survival. Secondary outcomes will focus on (1) qualitative assessments of symptoms using validated questionnaires, (2) quantitative improvements in the hormonal profile before and after initiation of TRT and surgery, and (3) allograft function and incidence of delayed graft function. The results of this study could provide novel insights into the benefits of TRT in improving surgical outcomes in men with ESRD undergoing kidney transplantation.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Testosterone Replacement Therapy
Testosterone Replacement Therapy
Testosterone Replacement Therapy
No Testosterone Replacement Therapy
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Testosterone Replacement Therapy
Testosterone Replacement Therapy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Hypogonadal (testosterone level \<300 ng/dL) with clinical symptoms of hypogonadism.
* Expected to undergo kidney transplantation within a 6-month period.
* Able and willing to comply with study procedures and follow-up visits.
Exclusion Criteria
* Any contraindications to testosterone therapy, including:
* History of Breast Cancer
* Severe untreated OSA
* Polycythemia (Hct \>54%)
* Uncontrolled chronic heart failure (CHF)
* A history of a Major Adverse Cardiac Event (MACE) within the past 6 months
* Interest in fertility within 1 year
* An unevaluated PSA \>4.0 ng/mL or a PSA \>3.0 ng/mL in individuals with risk factors for prostate cancer defined as:
* Men with African ancestry
* Men with first-degree relative with prostate cancer
* Known genetic mutations including BRCA1/2
* A history of Lynch Syndrome
* Abnormal DRE
* Participants already receiving testosterone or other androgen therapies.
* Severe cardiovascular or pulmonary conditions that pose a high surgical risk.
* Any condition that, in the opinion of the investigator, would make the subject ineligible for the study.
18 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of California, Los Angeles
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Nima Nassiri
Assistant Clinical Professor of Urology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of California, Los Angeles
Los Angeles, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PATS 20252050
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
IRB-24-5575
Identifier Type: -
Identifier Source: org_study_id